Global pharma giant AstraZeneca has secured US approval for Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor (ASI) designed to tackle persistently uncontrolled hypertension when used alongside existing blood pressure medicines.
The approval marks a significant step in a field where progress has been limited for decades, despite hypertension affecting an estimated 1.4 billion people worldwide.
Baxfendy works in a fundamentally different way from current therapies. It selectively blocks aldosterone synthase, reducing production of aldosterone—a hormone that drives blood pressure upward and contributes to cardiovascular and renal damage.
The US Food and Drug Administration (FDA) decision is backed by Phase III BaxHTN trial results, published in the New England Journal of Medicine.
The data showed statistically significant and clinically meaningful reductions in seated systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension already receiving at least two antihypertensive agents. The drug was generally well tolerated, with no unexpected safety signals reported.
Bryan Williams, Chair of Medicine at University College London and lead investigator of the BaxHTN trial, said: “We have been waiting for an innovative medication like Baxfendy for hypertension for many years. Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension.
"In addition, the nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients. Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.”
John M. Clymer, Executive Director, National Forum for Heart Disease & Stroke Prevention, said: “Hypertension remains a staggeringly widespread silent killer and a leading risk factor for stroke, heart attack, kidney damage and dementia.
"Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments. Innovative, new treatments could help millions protect their heart, kidney and brain health.”
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit at AstraZeneca, said: “The approval of Baxfendy offers a much-needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines."
Clinical trial results underscore the drug’s impact. In the BaxHTN study, patients receiving Baxfendy 2mg saw an average 15.7 mmHg reduction in seated systolic blood pressure, compared with 5.8 mmHg on placebo—yielding a placebo-adjusted reduction of 9.8 mmHg.
The 1mg dose produced a 14.5 mmHg reduction from baseline and an 8.7 mmHg placebo-adjusted effect. Outcomes were consistent across both uncontrolled and treatment-resistant patient groups.
